依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081291921292461293821293941294271293280.08
211.101317491318001317740.03
单位质量响应值RSD%判断
11672.2011871.531.20数据可信
供试品溶液-24021802批-匹伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133499-13349998.29596.155.7598.3096.155.75
2124068-12406891.35191.35
3128370-12837094.51994.52
4123231-12323190.73590.73
5143680-143680105.792105.79
6130663-13066396.20796.21
10min1136284-136284100.34697.745.81100.5197.905.81
2127213-12721393.66793.82
3132117-13211797.27897.44
4124016-12401691.31391.46
5145927-145927107.446107.62
6130873-13087396.36296.52
15min1136001-136001100.13797.305.77100.4797.635.77
2126677-12667793.27293.58
3131668-13166896.94797.27
4123475-12347590.91591.22
5145031-145031106.786107.14
6130060-13006095.76396.08
20min1135567-13556799.81897.145.83100.3297.635.83
2126447-12644793.10393.57
3131362-13136296.72297.20
4123378-12337890.84391.30
5145094-145094106.833107.37
6129734-12973495.52396.00
30min1135083-13508399.46296.735.90100.1397.385.89
2125751-12575192.59093.21
3130888-13088896.37397.02
4122993-12299390.56091.17
5144687-144687106.533107.24
6128824-12882494.85395.49
45min1134424-13442498.97696.475.7999.8197.285.79
2125337-12533792.28693.06
3130516-13051696.09996.90
4122518-12251890.21090.97
5143992-143992106.021106.91
6129298-12929895.20296.00
60min1134601-13460199.10796.165.93100.1097.135.93
2124841-12484191.92092.85
3129707-12970795.50396.47
4121973-12197389.80990.72
5143703-143703105.808106.87
6128743-12874394.79395.75
极限1134233-13423398.83695.865.95100.0096.995.94
2124715-12471591.82892.91
3129395-12939595.27396.40
4121322-12132289.32990.39
5143215-143215105.449106.69
6128236-12823694.42095.53
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.413843113846383847763851993857263849300.15
211.423895083899613897340.09
单位质量响应值RSD%判断
33736.2034127.320.82数据可信
供试品溶液-24021802批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min128712-287127.5917.374.987.597.374.97
228929-289297.6487.65
325145-251456.6486.65
428278-282787.4767.48
527831-278317.3587.36
628311-283117.4857.48
15min129959-299597.9207.862.907.937.882.91
230892-308928.1678.18
328604-286047.5627.57
430299-302998.0108.02
528886-288867.6377.65
629839-298397.8897.90
20min130165-301657.9757.763.798.007.793.80
229851-298517.8927.92
328994-289947.6657.69
430651-306518.1038.13
527528-275287.2787.30
628987-289877.6637.69
30min130418-304188.0427.823.508.087.863.49
231156-311568.2378.28
329000-290007.6677.70
428283-282837.4777.52
529236-292367.7297.77
629419-294197.7787.82
45min129690-296907.8497.772.307.907.822.30
229742-297427.8637.92
330077-300777.9528.00
429196-291967.7197.77
528145-281457.4417.49
629426-294267.7797.83
60min130333-303338.0197.872.648.087.942.62
230738-307388.1268.19
330127-301277.9658.03
428629-286297.5697.63
529138-291387.7037.77
629728-297287.8597.92
极限130214-302147.9887.832.628.077.912.64
230208-302087.9868.07
329772-297727.8717.95
428577-285777.5557.63
528742-287427.5997.67
630277-302778.0048.08
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081321881321821322491322391321011321920.05
211.101337421337731337580.02
单位质量响应值RSD%判断
11930.6912050.270.71数据可信
供试品溶液-24021802批-匹伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123037-12303788.93691.532.4088.9491.522.39
2127003-12700391.80391.80
3127778-12777892.36392.36
4128096-12809692.59392.59
5123082-12308288.96988.97
6130723-13072394.49294.49
10min1131561-13156195.09893.362.3095.2593.512.30
2128081-12808192.58292.74
3129087-12908793.30993.46
4129321-12932193.47993.63
5124192-12419289.77189.92
6132671-13267195.90096.06
15min1131219-13121994.85193.052.1295.1693.362.12
2127766-12776692.35592.66
3128801-12880193.10393.41
4128813-12881393.11193.42
5124096-12409689.70290.00
6131648-13164895.16195.48
20min1131087-13108794.75592.642.4495.2293.112.44
2126564-12656491.48691.95
3128204-12820492.67193.14
4128562-12856292.93093.40
5123041-12304188.93989.39
6131521-13152195.06995.54
30min1130677-13067794.45992.492.2095.0893.112.19
2126837-12683791.68392.30
3127567-12756792.21192.83
4128204-12820492.67193.29
5123393-12339389.19489.79
6131058-13105894.73495.37
45min1130247-13024794.14892.382.5694.9393.162.55
2126532-12653291.46392.23
3127687-12768792.29793.07
4127764-12776492.35393.13
5122553-12255388.58689.33
6132039-13203995.44396.24
60min1131128-13112894.78592.202.6495.7293.122.63
2126136-12613691.17692.10
3127573-12757392.21593.14
4127138-12713891.90192.83
5122210-12221088.33889.23
6131126-13112694.78395.73
极限1129541-12954193.63891.962.1894.7393.042.18
2125991-12599191.07292.14
3126986-12698691.79192.87
4127051-12705191.83892.92
5122953-12295388.87689.91
6130821-13082194.56395.67
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.413903563908633914713918773918383912810.17
211.423937983942573940280.09
单位质量响应值RSD%判断
34292.8134503.330.44数据可信
供试品溶液-24021802批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0002.74109.650.002.74109.65
221814-218145.6895.69
320860-208605.4405.44
420289-202895.2915.29
5-0.0000.00
6-0.0000.00
10min128824-288247.5177.783.147.527.783.19
230671-306717.9988.01
331072-310728.1038.11
429559-295597.7087.72
528816-288167.5157.51
629965-299657.8147.81
15min131697-316978.2667.903.188.287.913.16
228722-287227.4907.51
330327-303277.9097.93
430595-305957.9798.00
530341-303417.9127.92
629981-299817.8187.83
20min131065-310658.1018.022.698.138.062.66
231184-311848.1328.17
329910-299107.8007.84
430869-308698.0508.09
529690-296907.7437.77
631880-318808.3148.34
30min130871-308718.0517.812.998.097.852.99
230495-304957.9538.00
330048-300487.8367.88
429997-299977.8237.87
529953-299537.8117.85
628267-282677.3727.41
45min130742-307428.0177.852.378.077.912.35
229022-290227.5687.63
330911-309118.0618.12
430399-303997.9277.99
529699-296997.7457.80
629882-298827.7937.84
60min129933-299337.8067.672.477.877.742.44
228537-285377.4427.52
330303-303037.9027.98
429427-294277.6747.75
528579-285797.4537.52
629753-297537.7597.82
极限130587-305877.9777.753.398.067.833.35
228715-287157.4887.58
329748-297487.7587.85
429521-295217.6997.79
528555-285557.4477.52
631097-310978.1108.19
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081331201331031330571329201326251329650.16
211.101330981331761331370.05
单位质量响应值RSD%判断
12000.4511994.320.04数据可信
供试品溶液-24021802批-匹伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103930-10393075.08092.3411.4575.0892.3411.45
2122404-12240488.42688.43
3131589-13158995.06195.06
4133931-13393196.75396.75
5148250-148250107.097107.10
6126852-12685291.63991.64
10min1138083-13808399.75298.766.3099.8898.926.30
2124357-12435789.83689.98
3140604-140604101.573101.73
4136056-13605698.28898.45
5149810-149810108.224108.40
6131370-13137094.90395.06
15min1142860-142860103.20399.476.47103.4999.796.46
2123819-12381989.44889.74
3141673-141673102.346102.67
4135849-13584998.13898.46
5149219-149219107.797108.16
6132753-13275395.90296.21
20min1143668-143668103.78799.466.63104.2599.946.63
2123398-12339889.14489.59
3141553-141553102.259102.76
4135446-13544697.84798.34
5149204-149204107.786108.32
6132793-13279395.93196.40
30min1144429-144429104.33799.356.68104.97100.006.67
2123003-12300388.85889.45
3141024-141024101.877102.55
4135002-13500297.52698.18
5148658-148658107.392108.11
6133002-13300296.08296.71
45min1143859-143859103.92598.856.70104.7499.666.70
2122573-12257388.54889.29
3140653-140653101.609102.45
4134363-13436397.06597.88
5147819-147819106.786107.68
6131724-13172495.15895.95
60min1143730-143730103.83298.816.64104.8299.796.63
2122527-12252788.51489.40
3140325-140325101.372102.38
4134118-13411896.88897.86
5147727-147727106.719107.79
6132244-13224495.53496.48
极限1143106-143106103.38198.496.54104.5499.646.53
2122307-12230788.35589.39
3139874-139874101.046102.22
4133723-13372396.60297.74
5147068-147068106.243107.50
6131962-13196295.33096.44
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.413920183926443929893932663925743926980.12
211.423907643913323910480.11
单位质量响应值RSD%判断
34417.0034242.380.36数据可信
供试品溶液-24021802批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min126789-267897.0006.932.547.006.932.55
227138-271387.0917.09
326094-260946.8186.82
427316-273167.1387.14
526233-262336.8556.85
625563-255636.6806.68
15min127518-275187.1907.301.477.207.311.48
228106-281067.3447.36
327917-279177.2957.31
428613-286137.4777.49
527833-278337.2737.28
627537-275377.1957.21
20min128427-284277.4287.352.837.457.372.80
228205-282057.3707.39
327928-279287.2987.32
428837-288377.5357.56
528707-287077.5017.52
626649-266496.9636.99
30min128477-284777.4417.154.967.487.194.95
228173-281737.3627.40
326872-268727.0227.06
427570-275707.2047.24
528228-282287.3767.41
624862-248626.4966.53
45min126868-268687.0217.121.777.077.161.78
227929-279297.2987.35
327202-272027.1087.16
427713-277137.2417.29
526869-268697.0217.07
626807-268077.0057.05
60min128209-282097.3717.132.627.437.192.61
227003-270037.0567.12
327383-273837.1557.21
427630-276307.2207.28
527435-274357.1697.23
626077-260776.8146.87
极限128176-281767.3627.162.247.437.242.20
227156-271567.0967.17
327785-277857.2607.33
427738-277387.2487.32
527212-272127.1117.18
626436-264366.9086.98
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081355451354871352511351341350851353000.16
211.101351931358531355230.35
单位质量响应值RSD%判断
12211.1912209.280.02数据可信
供试品溶液-24021802批-匹伐他汀钙-pH4.5(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127706-12770690.64892.163.7690.6592.163.76
2129698-12969892.06192.06
3136050-13605096.57096.57
4133098-13309894.47594.47
5130700-13070092.77392.77
6121808-12180886.46186.46
10min1129903-12990392.20793.963.6392.3694.113.63
2132811-13281194.27194.42
3138669-13866998.42998.59
4135451-13545196.14596.30
5132743-13274394.22394.38
6124649-12464988.47888.62
15min1129431-12943191.87293.863.4792.1894.183.47
2132507-13250794.05594.37
3137934-13793497.90898.23
4135736-13573696.34796.67
5132780-13278094.24994.56
6125028-12502888.74789.04
20min1129618-12961892.00593.613.5592.4694.083.55
2132159-13215993.80894.28
3138038-13803897.98198.47
4135280-13528096.02496.50
5131706-13170693.48793.96
6124477-12447788.35688.80
30min1129477-12947791.90593.413.6892.5294.033.68
2131923-13192393.64194.26
3137640-13764097.69998.35
4135325-13532596.05696.69
5131453-13145393.30793.93
6123739-12373987.83288.42
45min1129207-12920791.71393.153.6392.4893.933.63
2131097-13109793.05593.83
3137416-13741697.54098.35
4134885-13488595.74396.54
5131142-13114293.08693.87
6123635-12363587.75888.49
60min1128458-12845891.18192.853.4192.1093.783.41
2131392-13139293.26494.20
3136531-13653196.91297.89
4133352-13335294.65595.61
5131607-13160793.41794.35
6123490-12349087.65588.53
极限1128164-12816490.97392.713.4292.0493.803.42
2131288-13128893.19094.28
3135949-13594996.49997.64
4133585-13358594.82195.94
5131473-13147393.32194.41
6123216-12321687.46088.49
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.413963123968473951553953513953203957970.19
211.423933423939123936270.11
单位质量响应值RSD%判断
34688.6134468.210.46数据可信
供试品溶液-24021802批-依折麦布-pH4.5(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183533-18353347.61243.1211.8047.6143.1211.80
2196892-19689251.07851.08
3147490-14749038.26238.26
4156522-15652240.60540.61
5151764-15176439.37139.37
6161029-16102941.77441.77
10min1299432-29943277.67976.493.7677.7676.563.77
2310615-31061580.58080.67
3278598-27859872.27472.34
4297578-29757877.19877.27
5296347-29634776.87976.94
6286469-28646974.31674.39
15min1333933-33393386.62987.051.6186.8487.251.62
2342505-34250588.85389.07
3331283-33128385.94286.13
4338025-33802587.69187.89
5339410-33941088.05088.24
6328115-32811585.12085.31
20min1354084-35408491.85791.691.1192.2192.041.11
2356806-35680692.56392.93
3353912-35391291.81292.14
4355028-35502892.10292.44
5355046-35504692.10792.45
6345770-34577089.70090.04
30min1368924-36892495.70795.481.0896.2195.981.08
2369612-36961295.88596.41
3371938-37193896.48996.97
4369541-36954195.86796.36
5367831-36783195.42395.92
6360473-36047393.51594.00
45min1376541-37654197.68397.460.9798.3598.120.97
2375299-37529997.36198.04
3379563-37956398.46799.11
4376953-37695397.79098.45
5376816-37681697.75498.41
6368866-36886695.69296.33
60min1376509-37650997.67597.930.9298.5098.740.91
2378536-37853698.20099.04
3381339-38133998.92899.73
4376673-37667397.71798.54
5380183-38018398.62899.44
6371609-37160996.40397.20
极限1375523-37552397.41998.030.8198.4199.010.81
2378495-37849598.19099.20
3380589-38058998.73399.70
4378299-37829998.13999.12
5381217-38121798.89699.88
6373164-37316496.80797.77
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